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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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ARK™ Methotrexate II Dilution Buffer is intended for dilution of specimens containing high concentrations of methotrexate for the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0004-00
In Commercial Distribution

  • 00812101031223 ()
5071-0004-00

  • Methotrexate therapeutic drug monitoring IVD, calibrator
ARK™ Methotrexate II Control is intended for use in quality control of the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0003-02
In Commercial Distribution

  • 00812101031216 ()
5071-0003-02

  • Methotrexate therapeutic drug monitoring IVD, control
ARK™ Methotrexate II Control is intended for use in quality control of the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0003-01
In Commercial Distribution

  • 00812101031209 ()
5071-0003-01

  • Methotrexate therapeutic drug monitoring IVD, control
ARK™ Methotrexate II Control is intended for use in quality control of the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0003-00
In Commercial Distribution

  • 00812101031193 ()
5071-0003-00

  • Methotrexate therapeutic drug monitoring IVD, control
ARK™ Methotrexate II Calibrator is intended for use in calibration of the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0002-00
In Commercial Distribution

  • 00812101031186 ()
5071-0002-00

  • Methotrexate therapeutic drug monitoring IVD, calibrator
The ARK™ Methotrexate II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.
ARK DIAGNOSTICS INC
5071-0001-01
In Commercial Distribution

  • 00812101031179 ()
5071-0001-01

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
The ARK™ Methotrexate II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.
ARK DIAGNOSTICS INC
5071-0001-00
In Commercial Distribution

  • 00812101031162 ()
5071-0001-00

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
The ARK Methotrexate Assay c-Pack (cobas c pack green reagent packs) is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.
ARK DIAGNOSTICS INC
5026-0001-03
In Commercial Distribution

  • 00812101030639 ()
5026-0001-03

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Ultrasonic Aspirator Console
STRYKER CORPORATION
5500050000
In Commercial Distribution

  • 07613327364675 ()
5500-050-000

  • Ultrasonic surgical system generator
Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
LIN-ZHI INTERNATIONAL, INC.
0011
In Commercial Distribution

  • B07600110 ()
0011

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
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